Acupuncture for treating a symptom cluster (pain, fatigue, sleep and neuropathy) for women with breast cancer: a feasibility study

Not Applicable

Active, not recruiting

• Conditions: breast cancer; Cancer - Breast

• Registration Number: ACTRN12622000590763
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-21
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

breast cancer diagnosis
- completed cancer modifying treatment
- female
- moderate to severe symptom burden of sleep disturbance, fatigue, pain and neuropathy. Moderate to severe symptom burden is defined as scoring greater than or equal to 4 on the ESAS-17 for two or more of these items.

Exclusion Criteria

-Recurrent or metastatic cancer
-Pregnancy
-Received acupuncture in the last 2 weeks
-Currently Receiving chemotherapy or radiotherapy
-Under 18 years old
-Persisting thrombocytopenia (Platelets < or = 80)
-Known coagulopathy
-Demand Pacemaker in situ: can participate but excluded from receiving electroacupuncture

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability: measured using the Acceptability of Intervention Measure questionnaire, collected through redCACP data collection software[6 weeks after starting treatment (at the endpoint)];Feasibility: measured using the Feasibility of Intervention Measure questionnaire, collected through redCAP data collection software[6 weeks after starting treatment (at the endpoint)];Appropriateness: measured using Intervention Appropriateness Measure questionnaire, collected through redCACP data collection software[6 weeks after starting treatment (at the endpoint)]

Secondary Outcome Measures

Name	Time	Method
symptom burden, measured using the Edmonton Symptom Assessment Scale, collected through redCACP data collection software [at baseline (start of trial), 6 weeks after starting treatment (at the endpoint) and 8 weeks after starting treatment (follow-up)];Quality of life, measured using the Patient Reported Outcome Measure Information System (PROMIS) self report measure. We will use the PROMIS-29 v2.0 profile items (Hays et al, 2018) collected through REDCap data collection software.[at baseline (start of trial), 6 weeks after starting treatment (at the endpoint) and 8 weeks after starting treatment (follow-up)];credibility and expectancy of participants: Credibility and Expectancy questionnaire, collected through redCACP data collection software [at baseline (start of trial), 6 weeks after starting treatment (at the endpoint) ]